ANDA 202143

AM REGENT

FDA Drug Application

Application #202143

Application Sponsors

ANDA 202143

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INTRAVENOUS

500MG/5ML (100MG/ML)

0

LEVETIRACETAM

LEVETIRACETAM

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-01-31
LABELING; Labeling	SUPPL	2	AP	2015-12-28	STANDARD
LABELING; Labeling	SUPPL	3	AP	2015-12-28	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-12-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	15

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202143
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"500MG\/5ML (100MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/31\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/28\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/28\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/28\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-12-28
        )

)